Clinical Trial Associate - Site Management

Plainsboro, NJ

Ambulatory Health Care Services

About the position

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference? Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex cross-functional improvement/innovation projects for the department (subset) of NACD and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools, and technology. Maintains responsibility for quality, performance, regulatory compliance, and patient safety related to managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems.

Responsibilities

• Executes all relevant services/tasks in support of the planning and quality delivery of clinical trials in line with established targets and metrics including communication of updates
• Responsible and accountable for tasks, processes and deliverables from trial start up through closure, including but not limited to management of clinical trial documents
• Monitoring of the Investigator Portal for, and Central IRB/REB submission of, SUSARs for assigned clinical trials
• Maintenance of systems, e.g., CTMS, eTMF and set up of study email/mailboxes
• Identification of problems in relation to tasks and key deliverables and mitigate accordingly with guidance from the Trial team
• Demonstration of technical proficiency within responsibility areas, staying updated with new practices, systems and technologies
• Contribute to Trial Core Team and other relevant teams and ensure transparency in communication and implementation of escalation pathway

Requirements

• A Bachelor's degree is required (science-related discipline preferred)
• Clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting preferred
• Demonstrated understanding of medical terminology and ICH-GCP principles
• Demonstrated computer skills (MS Office and clinical trial systems) and adaptability to new systems
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and stakeholder management skills
• Strong attention to detail and planning/organizing skills required

Benefits

• Inclusive recruitment process
• Equality of opportunity for all job applicants
• Commitment to creating an inclusive culture that celebrates diversity